NCT07259317 Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
| NCT ID | NCT07259317 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Corcept Therapeutics |
| Condition | Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-01-27 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).
Eligibility Criteria
Inclusion Criteria: * Signed and dated informed consent form prior to screening procedures * Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC) * Initial diagnosis of metastatic disease occurred ≤9 weeks prior to enrollment in the study * Life expectancy of ≥3 months * Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Able to provide informed consent and comply with protocol requirements * Able to swallow and retain oral medication and does not have uncontrolled emesis * Has adequate gastrointestinal absorption * Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted. * If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred \>12 months after completing the last dose, and no persistent treatment-related toxicities can be present. * Adequate organ function * Negative pregnancy test for patients of childbearing potential * Agree to use protocol defined precautions to avoid pregnancy Exclusion Criteria: * Any major surgery within 4 weeks prior to enrollment * Prior treatment as follows: 1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease 2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug * Received gemcitabine or nab-paclitaxel to treat their PDAC * Known germline or somatic breast cancer gene (BRCA) mutation * Peripheral neuropathy from any cause \>Grade 1 * Medical conditions requiring chronic or frequent treatment with corticosteroids * History of severe hypersensitivity or severe reaction to any of study drugs or their excipients * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators. * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation * Active infection with HIV, hepatitis C or hepatitis B virus * Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases * History of other malignancy within 3 years prior to enrollment * Taking protocol-prohibited medications * Concurrent treatment with other investigational treatment studies for cancer * Has received a live vaccine within 30 days prior to the study start date
Contact & Investigator
Sachin Pai
STUDY DIRECTOR
Corcept Therapeutics
Frequently Asked Questions
Who can join the NCT07259317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07259317 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07259317 currently recruiting?
Yes, NCT07259317 is actively recruiting participants. Contact the research team at corceptstudy558@corcept.com for enrollment information.
Where is the NCT07259317 trial being conducted?
This trial is being conducted at Scottsdale, United States, Los Angeles, United States, Orange, United States, Atlanta, United States and 10 additional locations.
Who is sponsoring the NCT07259317 clinical trial?
NCT07259317 is sponsored by Corcept Therapeutics. The principal investigator is Sachin Pai at Corcept Therapeutics. The trial plans to enroll 80 participants.